The Recall Desk
HighFDA (Devices)·Z-2487-2025·Announced 2025-09-10

RayStation Radiation Therapy Software Contains Non-Unique Patient Identifier Codes

RayStation radiation therapy planning software may use non-unique identifiers for patient imaging data, potentially causing patient identification errors during treatment planning. Affected versions are 7.0.0.19, 8.0.0.61, and 8.0.1.10.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II FDA recall with no reported illnesses or injuries. The hazard is data integrity in a high-risk medical context (radiation therapy), where non-unique patient identifiers could lead to treatment mix-ups. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

RayStation is a radiation therapy treatment planning system used in cancer treatment. The affected versions include RayStation 7 (software version 7.0.0.19), RayStation 8A (software version 8.0.0.61), and RayStation 8A Service Pack 1 (software version 8.0.1.10), all manufactured by RaySearch Laboratories AB. The recall concerns DICOM SOP Instance UID and Series Instance UID values from RayGateway—the interface connecting RayStation to Accuray's iDMS imaging system—which are not guaranteed to be unique.

In radiation therapy treatment planning, patient identification is critical. DICOM identifiers link imaging data to patient records. Non-unique identifiers could cause imaging data from different patients to be confused or mixed during treatment planning, potentially compromising treatment accuracy and patient safety.

The affected software has been distributed worldwide to healthcare facilities in the United States and internationally. Within the US, distribution includes facilities in Alabama, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maryland, Minnesota, Mississippi, New York, North Carolina, Ohio, Oklahoma, South Carolina, Washington, and Wisconsin. International distribution includes Canada, China, Colombia, France, Germany, Hong Kong, Italy, Japan, Netherlands, Poland, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, and Ukraine.

The recalled product

Product
RayStation with the following product descriptions: 1. RayStation 7, Software Version: 7.0.0.19. 2. RayStation 8A, Software Version: 8.0.0.61. 3. RayStation 8A Service Pack 1, Software Version: 8.0.1.10. Product Description: Radiation Therapy Treatment Planning Sys
Manufacturer
RAYSEARCH LABORATORIES AB
Category
Medical Device — Radiation Therapy Planning Software
Hazard
  • non-unique-identifier
  • patient-identification-error
  • data-integrity

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • 1. Software Version: 7.0.0.19
  • UDI: 0735000201006820171130. 2. Software Version: 8.0.0.61
  • UDI: 0735000201011220180608. 3. Software Version: 8.0.1.10
  • UDI: 0735000201013620180928. Expiration Date: 2023-10-04

Distribution

Distributed nationwide across the United States.

Related recalls

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